Development of Walk Assist Device to Improve Community Ambulation

Active, not recruiting

Phase 1 Results N/A

Trial Description

Hypothesis/Specific Aims:
The purpose of this study is to determine the effect of training with the Stride Management Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal drive to the lower limb muscles in patients post stroke. The investigators hypothesize that long-term SMA use would strengthen the connections between the motor areas of the brain and the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal excitability of the lower limb muscles compared to those in the IPT group.

Detailed Description

This is a randomized control trial comparing task specific training with the Stride Management Assist (SMA) device verses an impairment based physical therapy (IPT) approach on functional walking ability in outpatient stroke rehabilitation. Participants between the ages of 18-80 and who are 30 days or greater post stroke will be included.
This SMA robotic device assists hip flexion and extension, for each side independently. It is controlled through software run on a tablet. The device weighs 2.8 kgs, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. It comes in 3 sizes (small, medium and large). It is worn around like a belt with the motors near the hips and straps on the thighs. The SMA device allows users to increase their stride length by providing assist with the motors in flexion and extension. This device is 1) simple to use in the clinical setting; 2) easily adjustable to alter according to the requirements of each subject; and, 3) can quantify the amount of assistance required to facilitate walking patterns.
Participants post stroke 30 days or greater will be recruited from inpatient, day rehabilitation and outpatient clinics. Participants will be scheduled for 18 Sessions of outpatient physical therapy plus 3 sessions of testing. The amount of sessions provided will be dependent upon compatibility with the device and ability to tolerate the device. A participant will continue with each session of the study as deemed appropriate by research staff.
- A. Phase I. (session 0): After consenting, subjects will undergo a physical evaluation and screening exam by a licensed physical therapist. If they meet study criteria, they will be randomly placed into either the SMA group or the IPT group using a random number generator and they will be entered into the study. Once they are enrolled, baseline outcome measures will be assessed by a blinded research physical therapist.
- B. Phase II. (sessions 1-9):
- Stride Management Assist Group: Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
- Impairment Based Physical Therapy Group: Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
- C. Phase III. (session 10): Mid treatment assessment. Outcome measures will be assessed by a blinded research physical therapist.
- D. Phase II. (sessions 11-19):
- Stride Management Assist Group: Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
- Impairment Based Physical Therapy Group: Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
- E. Phase IV. (session 20): Post Testing. Outcome measures will be assessed by a blinded research physical therapist.
All testing and training sessions will be under the supervision of a licensed physical therapist. All subjects will be permitted to stop physical activity or rest at any time during the study. Adverse events will be recorded.
The investigators anticipate this study will help determine if the Stride Management Assist is a practical option to better strengthen the connections between the brain and the lower limbs. The investigators do not foresee any potential pitfalls.

Conditions

Interventions

  • The Stride Management Assist (SMA) System Device
    Intervention Desc: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
    ARM 1: Kind: Experimental
    Label: Stride Management Assist (SMA) System
    Description: Participants will be randomized into either the SMA group or impairment based (IPT) group.
  • Impairment based therapy Other
    Intervention Desc: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
    ARM 1: Kind: Experimental
    Label: Impairment based therapy
    Description: Impairment based therapy will include traditional functional mobility training physical therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in 10 meter walk test from baseline in gait speed Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary Activities-Specific Balance Confidence Scale (ABC) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary Numeric Pain Rating Scale (NPRS) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary Stroke Specific Quality of Life Scale (SS-QOL) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary The Modified Falls Efficacy Scale (mFES) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary Patient Health Questionnaire-9 (PHQ-9) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary Transcranial Magnetic Stimulation (TMS) Session 0 (initial visit);Session 20 (between 6-8 weeks) No
Secondary Change in 6 Minute Walk Test from baseline in distance (6MWT) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No
Secondary Berg Balance Scale (BBS) Session 0 (initial visit); Session 10 (at approximently 4 weeks);Session 20 (between 6-8 weeks) No

Sponsors